A Study of LY3053102 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: LY3053102; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01736241

14514

I6I-MC-LMRA (Other Identifier)

Details and patient eligibility

About

The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).

Enrollment: 41 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal blood pressure
• Female participants were not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
• Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion criteria

• Had known allergies to LY3053102 or related compounds
• Had a history of significant disease that may have affected the actions of drugs or may pose a risk when taking the study medication
• Had a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids
• Heavy smokers (more than 10 cigarettes a day)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

41 participants in 2 patient groups, including a placebo group

LY3053102

Experimental group

Description:

A single 2-, 7-, 20-, 50-, 150-, or 405-milligrams (mg) dose of LY3053102 was subcutaneously administered to newly randomized participants in 6 escalating dose level cohorts. The dose was escalated based on the safety results over at least a 7-day evaluation period postdose. The dose escalation occurred over 13 weeks proceeding according to tolerability at each dose level.

Treatment:

Drug: LY3053102

Placebo

Placebo Comparator group

Description:

A single dose of LY3053102-matching placebo was administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort over 13 weeks.

Treatment:

Drug: Placebo